While male incontinence is a common and often neglected problem, the distress, embarrassment and inconvenience imposed on individuals suffering from involuntary urination warrants the development of non-invasive solutions to this condition.
To date, one of the common means of preventing the involuntary flow of urine in incontinent males has been to clamp the penis via a device that becomes painful, socially restrictive and difficult to keep clean. Such devices cause pressure to be applied upon the urethra, which consequently restricts the flow of urine through the penis. Another means of incontinence control is to place the penis in a pouch with a water-tight seal at the base of the penis and collect urine in a discharge bag.
U.S. Pat. No. 4,942,886 (entitled “External Incontinency Device” and issued to Timmons on Jul. 24, 1990) discloses a device having rigid members hinged together at one end and a ratchet portion with a plurality of recesses. When a strap is placed in one of the recesses, the two halves of the device are caused to maintain a predetermined position of clamping the penis. Unfortunately, due to the nature of the ratchet recess portion, inadvertent pressure against one or both of the sides of the device can cause a tightening of the device and a subsequent, excessive or pathological constriction of the penis.
One of the more popular devices for treating male incontinence is sold under the trademark Bard Cunningham Clamp.RTM. This device, too, has a ratchet-type closure mechanism that is subject to the same types of difficulties regarding any inadvertent bumping or touching thereof.
While not specifically addressing incontinence, U.S. Pat. No. 4,139,007 (entitled “Method and Apparatus for Conception” and issued to Diamond on Feb. 13, 1979) also discloses a male contraceptive device that prevents the leakage of semen into the female vagina. This device also has a ratchet recess portion, which is also subject to the same problems as experienced with Timmons.
To substitute for the rachet mechanism, Velcro® has been used in various devices. For example, U.S. Pat. Nos. 3,155,096 and 3,866,611 both feature the use of Velcro® fasteners as the closure mechanism. (The former, entitled “Male Incontinence Clamp” issued to Outwin on Nov. 3, 1964; the latter, entitled “Incontinence Device”, issued to Baumrucker on Feb. 18, 1975.) Unfortunately, as lint and other foreign materials become embedded in the operating mechanism (i.e., hooks and eyes) of the material, Velcro® has a tendency to become less efficient. Over a period of time, therefore, such devices become less useful.
U.S. Pat. No. 3,203,421 (entitled “Incontinence Clamp Device” and issued to Bialick on Aug. 31, 1965) discloses a device in which a knurled knob is used to tighten together the two portions of the hinged device. The tension appears to be predetermined, and the release of the penis is accomplished by completely removing the device, thus making use thereof at a urinal impossible. Two hands are required to reposition the device. While trying to operate the device, there is also a certain risk involved in dropping any of the parts thereof.
U.S. Pat. No. 5,415,179 (entitled “Male Urinary Incontinence Device” and issued to Mendoza on May 16, 1995) discloses a device comprising a “U-shaped “lower unit with a hinged upper bar which closes across the open section of the lower unit. The upper bar has a screw mechanism with a pad that causes compression of the penis when the pad is screwed down on the penis. While this will create sufficient pressure to stop the flow of involuntary urine, there is the risk of reducing or stopping the blood flow to the penis. As there is no direct pressure on the urethra, the pressure must be applied to the entire cross-section of the penis and the pressure sufficient to close the urethra. In addition, the mechanism is not convenient for voluntary urination as the complete device must be removed and reapplied using both hands.
U.S. Pat. No. 5,571,125 (entitled “Penis—Clamping Device for the Incontinent” and issued to Chadwick on Nov. 5, 1996) discloses a hinged clamshell device that can easily open and close. The device employs a hinged section with padded rigid straight jaws that are held shut with a screw/spring closure device. The closure device allows the user to adjust the pressure applied to the penis. The closure device also employs a quick release apparatus. However the disadvantage of this device is the hinge-jaw design and the establishment of an uneven pressure distribution on the penis. Since the jaws of the device are straight and unyielding, the pressure will be greatest on the hinged side where the jaws pinch down on the penis and there is no direct pressure on the urethra.
U.S. Pat. No. 5,184,629 (entitled “Male Urinary Anti-incontinence Device and Method” and issued to Erickson and Timm on Feb. 9, 1993) discloses a hinged cradle member with an elastic strap closure mechanism. The cradle member includes integral hinges situated about an axis perpendicular to the penile shaft and interconnecting the dorsal and ventral sections of the device through which the shaft of the penis is placed. The unique aspect of this device is an integral urethral occlusion pad on the ventral member such that upon closure and securing with the elastic (velcro) strap, the urethra is occluded. The disadvantage of this device is that it folds along the length of the penis and requires a substantial length of shaft for placement. In addition, there is no means of adjusting the amount of pressure applied to the penis to occlude the urethra.
The foregoing approaches to alleviating the problem of urinary incontinence in men leave much to be desired, since these designs offer little in the way of comfort or convenience for the user. In addition, none of these clamps is easy to clean, or are any capable of adjusting pressure directly upon the urethra. It should be obvious to the casual observer that such devices are neither comfortable nor efficient in resolving the problems imposed by an incontinent condition. In fact, such clamps are sometimes not only unworkable, but are actually dangerous when residual urine bums the skin or when inadvertent tightening causes penile constriction.
There is a need for an improved penile clamp that is safe, comfortable, easily cleanable and more socially practical (i.e., utilizing one-handed operation) than that heretofore devised. The ease of attachment and usage, as well as an emergency quick release, should also be combined with infinitely variable adjustment to enable the application of different pressures to accommodate the individual needs of users. For sanitary reasons, it is preferable that the clamping device does not absorb urine through the use of absorptive materials (pads).